Interleukin-2 With and Without Antiretroviral Therapy to Treat HIV-1 Infection
Tracking Information | |
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First Received Date ICMJE | March 29, 2005 |
Last Updated Date | June 10, 2011 |
Start Date ICMJE | March 2005 |
Primary Completion Date | February 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
Mean changae in CD4+ T lymphocyte count from baseline to Week 32 in the three study groups. [ Time Frame: 32 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE |
Mean changae in CD4+ T lymphocyte count from baseline to Week 32 in the three study groups. |
Change History | Complete list of historical versions of study NCT00106730 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Interleukin-2 With and Without Antiretroviral Therapy to Treat HIV-1 Infection |
Official Title ICMJE | A Randomized, Open-Label, International Study of Subcutaneous Recombinant Interleukin-2 (rIL-2, Aldesleukin) With and Without Concomitant Antiretroviral Therapy in Participants w/HIV-1 Infection and CD4+ Cell Counts Greater Than or Equal to 300/mm(3) |
Brief Summary | This study will determine the safety and side effects of interleukin-2 (IL-2) taken with or without anti-HIV drugs and will see if IL-2 with or without anti-HIV drugs causes an increase in CD4 cells or a change in HIV viral load compared with no therapy at all. IL-2 is a protein that is produced naturally in the body and helps boost production of infection-fighting CD4 cells. HIV-infected patients 18 years of age and older who have not previously taken IL-2 or taken any anti-HIV drug within 1 year of entering this study may be eligible for the study. Candidates are screened with a physical examination and blood tests during at least two screening clinic visits. Participants are assigned by chance to one of the following three treatment groups:
Patients in the first two groups may begin anti-HIV therapy at any time they or their doctors believe it would be in their best interest to do so, and patients in the third group may begin continuous anti-HIV therapy or, conversely, stop all anti-HIV drugs, at any time it is believed to be in their best interest to do so. All patients are followed in the clinic at least once a month for 8 months and then at least every 4 months for up to 2 years. The follow-up includes blood tests and possibly a visit with a doctor or nurse. Patients who develop side effects may need to be seen more frequently and may require additional blood and urine tests. Patients receiving IL-2 are seen for a clinical examination or blood tests, or both, to ensure that they are well before receiving each cycle. They are also seen on the last day of the dosing cycle and once again about one month after each cycle. They may need to be seen more often if they have a history of serious side effects during prior IL-2 treatments or if they develop serious side effects. Women who can become pregnant have a pregnancy test before starting each IL-2 cycle. Some of the blood drawn for this study is used for genetic tests, and some blood is collected and stored for future studies. |
Detailed Description | The purpose of this study is to compare the effects of subcutaneous (SC) recombinant interleukin-2 (rIL-2) administered with and without concomitant peri-cycle highly active antiretroviral therapy (HAART) to no therapy on CD4+ T lymphocyte count in patients with HIV-1 infection and CD4+ T lymphocyte count greater than or equal to 300 cells/mm(3). |
Study Type ICMJE | Interventional |
Study Phase | Phase 2 |
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment |
Condition ICMJE |
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Intervention ICMJE | Drug: Interleukin-2, Proleukin
N/A |
Study Arm (s) | |
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 9 |
Completion Date | June 2011 |
Primary Completion Date | February 2011 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE |
Documented HIV-1 infection by any licensed ELISA test and confirmed by a second method (e.g. Western Blot); or any one of the following prior to randomization: detectable HIV p24 antigen, quantifiable plasma HIV RNA, or proviral DNA. Greater than or equal to 18 years of age. The following clinical laboratory values obtained within 45 days prior to randomization: One CD4+ T cell count greater than or equal to 300 cells/mm(3). (For participants who are status post-splenectomy, also a CD4+ cell percentage on this occasion greater than or equal to 20%); AST or ALT less than 5 times the upper limit of normal (ULN) range; Total or direct bilirubin less than or equal to 2 X ULN (Participants with hyperbilirubinemia due to Gilbert's syndrome or indinavir or atazanavir therapy may have a serum bilirubin up to 5 X ULN); Serum creatinine less than or equal to 2 mg/dl (177 micro mol/L); Sodium within normal limits; Granulocyte count greater than or equal to 1000/mm(3); Hemoglobin greater than or equal to 10 gm/dl; Platelet count greater than or equal to 50,000 cells/mm(3). Ability to provide informed consent. Ability to obtain HAART regimens consisting of greater than or equal to 1 protease inhibitor and greater than or equal to 2 nucleoside or nucleotide reverse transcriptase inhibitors. EXCLUSION CRITERIA: Any prior history of rIL-2 use. Use of any approved or experimental antiretroviral drug (including hydroxyurea) within one year prior to randomization. In the judgment of the clinician, any current indication for continuous antiretroviral therapy, or any contraindication to antiretroviral therapy. Evidence of virological failure on a protease inhibitor- or nonnucleoside reverse transcriptase-based antiretroviral regimen. Use of systemic corticosteroids, chemotherapy, or experimental cytotoxic drugs within 45 days prior to randomization. Use of any agents (approved or experimental) with clinically significant immunomodulatory effects within 8 weeks prior to randomization. History of any AIDS-defining illness or any of the following conditions: extrapulmonary Pneumocystis carinii disease; multi-dermatomal Herpes zoster (greater than or equal to 10 lesions in a non-contiguous site); American trypanosomiasis (Chagas disease) of the CNS; Penicillium marneffii disease; visceral leishmaniasis; non-Hodgkin's lymphoma of any cell-type; Hodgkin's lymphoma; bartonellosis; microsporidiosis (greater than 1 month's duration); nocardiosis; invasive aspergillosis; or Rhodococcus equi disease. Concurrent malignancy requiring cytotoxic chemotherapy. Any CNS abnormality that requires ongoing treatment with antiseizure medication. Current or historical autoimmune/inflammatory diseases including: Inflammatory bowel disease, psoriasis, optic neuritis, or any autoimmune/inflammatory diseases with potentially life-threatening complications. Significant cardiac, pulmonary, renal, hepatic, gastrointestinal, CNS, psychiatric disease or illicit substance use/abuse that in the opinion of the investigator would make the participant a poor candidate for study participation. Pregnancy (for women of childbearing potential, a negative pregnancy test, urine or serum, is required within 14 days prior to randomization). Breastfeeding. |
Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Administrative Information | |
NCT Number ICMJE | NCT00106730 |
Other Study ID Numbers ICMJE | 050123, 05-I-0123 |
Has Data Monitoring Committee | |
Responsible Party | Jorge A. Tavel, M.D./National Institute of Allergy and Infectious Diseases, National Institutes of Health |
Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | National Institutes of Health Clinical Center (CC) |
Verification Date | June 2011 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |